A Single-arm, Single-center, Open-label, Pilot Clinical Study to Evaluate the Efficacy and Safety of Transcatheter Arterial Micro-Embolization (TAME) Using Nexsphere-F in Patients With Chronic Pain in Elbow or Wrist
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Rate of subjects with a 50% or more reduction in QuickDASH Score Change
研究概览
简要总结
In patients with chronic elbow or wrist pain, the pain is controlled by conventional conservative therapy The pain reduction effect of Nexsphere-F embolization in patients who need additional treatment It is intended to demonstrate safety.
详细描述
This clinical trial is a single cancer, single center, open label, and pilot clinical trial that demonstrates the performance and safety of Nexsphere-F for patients aged 19 to 80 who need additional treatment because their pain is not controlled even after taking existing treatments.
In addition, through this clinical trial, complications of embolization and Nexsphere-F and It checks the safety of side effects. Therefore, in this study, TAME treatment for patients with chronic elbow pain 2 to 7 months, 1 month later, 3 months, 6 wah VAS score reductions and QuickDASH scores, PRTEE score primary 6 Evaluate the reduction rate of medication, discontinuation rate of combination therapy, and occurrence of abnormal cases during the follow-up period. For patients with chronic wrist pain, VAS score after 2 to 7 days, 1 month, 3 months, and 6 months of TAME treatment QuickDASH score reduction rate, drug reduction rate after 6 months, discontinuation rate of combination therapy, and follow-up period the investigators will evaluate the effectiveness and safety of Nexsphere-F by evaluating whether abnormal cases occur during the period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Those aged 19 to 80
- •Anyone who can provide a consent form
- •A person with a life expectancy of at least 12 months
- •Those who have not responded or failed in preservation treatment for at least three months(e.g. NSAIDS/physical therapy/steroidal joint injections, etc.)
- •VAS score of 4 or higher and moderate-severe elbow or wrist pain
排除标准
- •Those with a VAS Score of less than 4 and Mild Elbow or Wrist Pain
- •Chronic Renal Insufficiency(Serum creatinine > 2mg/dL)
- •allergy to iodide contrast agents that do not respond to steroids
- •Those with acute infection or malignancy
- •Those who have previously had elbow or wrist surgery
- •Those with Bleeding Diabetes that cannot be calibrated
研究组 & 干预措施
Experimental
If abnormal blood vessels related to pain are identified by angiography, selective embolization is performed using Nexsphere-F.
干预措施: Transcatheter Arterial Micro-Embolization (Device)
结局指标
主要结局
Rate of subjects with a 50% or more reduction in QuickDASH Score Change
时间窗: 2~7days,1 month, 3 months, 6 months
Descriptive statistics (mean, standard deviation, median, minimum and maximum) are presented for each visit compared to the average change rate baseline of the QuickDASH score before and after clinical trial medical device application.
次要结局
- Rate of VAS Score (patient pain intensity) Change(2~7days,1 month, 3 months, 6 months)
- The rate of reduction of medication(6 months)
- Rate of Changes in symptoms according to in QuickDASH Score(2~7days,1 month, 3 months, 6 months)
- Rate of Changes in symptoms according to the Patient-Rated Tennis Elbow Evaluation (PRTEE) Score(2~7days,1 month, 3 months, 6 months)